Active — Not RecruitingNot Applicable

Clinical Study to Evaluate the Safety and Efficacy of Candela Technology

United States, Israel500 participantsStarted 2023-10-04

Plain-language summary

This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. At least 18 years of age or older
✓. Fitzpatrick skin type I-VI
✓. Willingness to provide signed, informed consent to participate in the study
✓. Able and willing to comply with the treatment/follow-up schedule and requirements and pre and post treatment instructions.
✓. Willing to receive clinical treatments with the study device to be utilized and comply with all study (protocol) requirements.
✓. Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
✓. Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study.

✕. Pregnant or planning to become pregnant, or breast feeding during the study
✕. Skin cancer in the treatment area or history of melanoma in the treatment area
✕. History of current cancer and subject has undergone chemotherapy within the last 12 months
✕. Severe concurrent conditions, such as cardiac disorders, per investigator discretion
✕. Impaired immune system or use of immunosuppressive medications as deemed inappropriate per investigator discretion
✕. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
✕. Pacemaker or internal defibrillator or any active electrical implant anywhere in the body if to be treated with an RF based device
✕. Superficial metal or other implants in the treatment area, except superficial dental implants, unless these implants can be removed or covered with rolled gauze during treatment if to be treated with an RF based device

Numerical Rating Scale (NRS)

Timeframe: From the first treatment to the last treatment, up 132 weeks.

Post-treatment Assessment Severity Scale

Timeframe: From the first treatment to the last treatment, up to 132 weeks.

NCT IDNCT06202274

SponsorCandela Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-10-04

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. At least 18 years of age or older
✓. Fitzpatrick skin type I-VI
✓. Willingness to provide signed, informed consent to participate in the study
✓. Able and willing to comply with the treatment/follow-up schedule and requirements and pre and post treatment instructions.
✓. Willing to receive clinical treatments with the study device to be utilized and comply with all study (protocol) requirements.
✓. Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
✓. Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study.

✕. Pregnant or planning to become pregnant, or breast feeding during the study
✕. Skin cancer in the treatment area or history of melanoma in the treatment area
✕. History of current cancer and subject has undergone chemotherapy within the last 12 months
✕. Severe concurrent conditions, such as cardiac disorders, per investigator discretion
✕. Impaired immune system or use of immunosuppressive medications as deemed inappropriate per investigator discretion
✕. Herpes Simplex Virus (HSV) in the intended treatment area unless treated following a prophylactic regimen
✕. Pacemaker or internal defibrillator or any active electrical implant anywhere in the body if to be treated with an RF based device
✕. Superficial metal or other implants in the treatment area, except superficial dental implants, unless these implants can be removed or covered with rolled gauze during treatment if to be treated with an RF based device